臨床研究等提出・公開システム

Date of registration	Nov. 05, 2024
Last modified on	April. 10, 2025
Trial ID	jRCT2031240458

Scientific Title	A Phase 1,randomized,placebo-controlled,double-blind, single and multiple dose study of M136101 in healthy subjects.
Public Title	Single and multiple dose study of M136101 in healthy subjects.

Contact for Scientific Queries	Name	Nishiura Tomoyuki
	Affiliation	Maruho Co.,Ltd. Kyoto R&D Center
	Address	93 Chudoji Awatacho, Shimogyo-ku, Kyoto
	Telephone	+81-75-325-3279
	E-mail	ctinfo@mii.maruho.co.jp
Contact for Public Queries	Name	- Clinical Trials Information
	Affiliation	Maruho Co.,Ltd. Kyoto R&D Center
	Address	93 Chudoji Awatacho, Shimogyo-ku, Kyoto
	Telephone	+81-75-325-3279
	E-mail	ctinfo@mii.maruho.co.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Nov. 24, 2024
Actual date of first enrollment		Nov. 24, 2024
Target sample size		24
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Males who are 18 to 44 years of age at the time of informed consent.
	Exclusion Criteria	(1)individuals with a history of or concomitant diseases that are considered inappropriate for participation in a clinical trial, such as serious cardiac, hepatic, pulmonary, renal, or hematological diseases. (2)Individuals with abnormal findings at the administration site. (3)Individuals who are judged to be unsuitable as subject by the principal (sub) investigator.
	Age Minimum	18age old over
	Age Maximum	45age old not
	Gender	Male
Health Condition(s) or Problem(s) Studied		Dry eye with meibomian gland dysfunction/Chalazion
Intervention(s)		M136101 or placebo will be topically applied to the eyelid and eyelid margin as a single dose and twice daily for 7 days
Primary Outcome(s)		Tolerability, Safety, PK

Primary Sponsor	Maruho Co.,Ltd.

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Medical Corporation Shinanokai Shinanozaka Clinic Institutional Review Board
Address	Yotsuya Medical Bldg., 20, Samon-cho, Shinjuku-ku, Tokyo
Telephone	+81-3-5366-3006
E-Mail	h-ogura@trcp.co.jp
Approval Status	Approval
Date of approval	Nov. 13, 2024

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	April. 10, 2025	(this page)	Changes
2	Dec. 05, 2024	Detail	Changes
1	Nov. 05, 2024	Detail

List of change history